Senior Medical Writer - Remote

Overview

Spyre Therapeutics is a clinical-stage biotechnology company that aims to create next-generation inflammatory bowel disease (IBD) and other immune-mediated disease products by combining best-in-class antibody engineering, dose optimization, and rational therapeutic combinations. Spyre's pipeline includes investigational extended half-life antibodies targeting α4β7, TL1A, and IL-23.

In Short

• Author clinical study protocols, amendments, IBs, and other supporting documents.
• Review or develop document timelines in collaboration with the team and CROs.
• Co-author protocols and IBs with cross-functional SMEs.
• Coordinate the finalization and publication of documents.
• Author CSRs, clinical and nonclinical data summaries for INDs, CTAs, BLAs, and MAAs.
• Identify risks and contribute to risk mitigation for submission activities.
• Contribute to the maintenance of document templates and training materials.
• Advocate for best practices in Medical Writing.
• Work in a fast-paced, dynamic environment.
• Participate in professional development opportunities.

Requirements

• Bachelor's degree in a scientific discipline; advanced degree is a plus.
• A minimum of 4+ years of regulatory medical writing experience.
• Proven track record in developing clinical study documents.
• Strong knowledge of global pharmaceutical regulations.
• Excellent leadership, collaboration, and communication skills.
• Strong problem-solving and critical thinking abilities.
• Ability to meet deadlines and adapt to changing priorities.
• Proficiency in word processing software and document management systems.

Benefits

• Market competitive compensation and benefits package.
• Unlimited PTO.
• Two, one-week company-wide shutdowns each year.
• Commitment to provide professional development opportunities.
• Remote working environment with frequent in-person meetings.